A Drug-Drug Interaction Study to Evaluate the Effect of Vapendavir on the Pharmacokinetics of Midazolam in Healthy Male and Female Volunteers

NCT ID: NCT02204501

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-06-30

Brief Summary

The primary aim of this Phase 1 study is to evaluate the effect of vapendavir daily doses of 528 mg daily (QD) and 264 mg twice daily (BID) on the pharmacokinetic (PK) profile of midazolam, a cytochrome (CYP) 3A4 substrate. Additionally, the effect of midazolam on the PK profile of vapendavir, a PK profile comparison of vapendavir in males and females, as well as the safety of vapendavir will also be assessed.

Conditions

Drug-Drug Interaction Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Vapendavir 528 mg QD

Twelve subjects (6 male and 6 female) will receive 528 mg vapendavir (achieved with four 132 mg vapendavir capsules) QD in the morning for seven days

Group Type: EXPERIMENTAL

Midazolam 5mg Syrup

Intervention Type: DRUG

All twenty four subjects will receive 5 mg midazolam syrup at four different time points during the study for a total of four non-subsequent dosing days.

• On Study Days 0 and 12, subjects will receive only 5 mg midazolam syrup dosed in the morning.
• On Study Days 6 and 9, subjects will have 5 mg midazolam syrup co-administered with their assigned dose of vapendavir in the morning. Co-administration of midazolam will not occur at the time of the evening dose for Group B.

Vapendavir 528 mg QD

Intervention Type: DRUG

Twelve subjects (6 male and 6 female) will receive 528 mg vapendavir (achieved with four 132 mg vapendavir capsules) QD in the morning for seven days

Vapendavir 264 mg BID

Twelve subjects (6 male and 6 female) will receive 264 mg vapendavir (achieved with two 132 mg vapendavir capsules) BID daily as divided dose given in the morning and evening 12 hours apart for seven days.

Group Type: EXPERIMENTAL

Midazolam 5mg Syrup

Intervention Type: DRUG

All twenty four subjects will receive 5 mg midazolam syrup at four different time points during the study for a total of four non-subsequent dosing days.

• On Study Days 0 and 12, subjects will receive only 5 mg midazolam syrup dosed in the morning.
• On Study Days 6 and 9, subjects will have 5 mg midazolam syrup co-administered with their assigned dose of vapendavir in the morning. Co-administration of midazolam will not occur at the time of the evening dose for Group B.

Vapendavir 264 mg BID

Intervention Type: DRUG

Twelve subjects (6 male and 6 female) will receive 264 mg vapendavir (achieved with two 132 mg vapendavir capsules) BID daily as divided dose given in the morning and evening 12 hours apart for seven days.

Interventions

Midazolam 5mg Syrup

All twenty four subjects will receive 5 mg midazolam syrup at four different time points during the study for a total of four non-subsequent dosing days.

• On Study Days 0 and 12, subjects will receive only 5 mg midazolam syrup dosed in the morning.
• On Study Days 6 and 9, subjects will have 5 mg midazolam syrup co-administered with their assigned dose of vapendavir in the morning. Co-administration of midazolam will not occur at the time of the evening dose for Group B.

Intervention Type: DRUG

Vapendavir 264 mg BID

Twelve subjects (6 male and 6 female) will receive 264 mg vapendavir (achieved with two 132 mg vapendavir capsules) BID daily as divided dose given in the morning and evening 12 hours apart for seven days.

Intervention Type: DRUG

Vapendavir 528 mg QD

Twelve subjects (6 male and 6 female) will receive 528 mg vapendavir (achieved with four 132 mg vapendavir capsules) QD in the morning for seven days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Must be male or female between 18 and 55 years of age (inclusive) with BMI between 18 and 30 kg/m2 (inclusive), and weight ≥50 kg at the time of screening;
• Capable of giving written informed consent;
• Subject is able to understand and comply with the protocol requirements, instructions and restrictions;
• Healthy on the basis of physical examination, medical history, medication usage, vital signs (VS), electrocardiograms (ECGs), and clinical laboratory tests;
• Female subjects who are not post-menopausal for at least 2 years or surgically sterile with complete hysterectomy or bilateral oophorectomy and male subjects who are not surgically sterile via vasectomy, must agree to use a double barrier method of birth control, such as a condom plus spermicidal agent (foam/gel/film/cream/suppository); and
• Female subjects must not be breastfeeding or pregnant.

Exclusion Criteria

• Positive results for Hepatitis B, Hepatitis C, or HIV;
• Frequent use (defined as > 5 times/day) of tobacco products, including cigarettes, cigars, chewing tobacco;
• A medical history of significant hematological, gastrointestinal, respiratory, renal, hepatic, cerebrovascular, immunologic, psychiatric or cardiovascular disease or event;
• Current or recent respiratory infection (defined as within 14 days of first study visit participation)
• Presence or history of significant allergy;
• Clinically significant abnormalities noted on ECG;
• Screening vital signs representing sustained elevated systolic blood pressure <90 mmHg or >140 mmHg, and/or diastolic blood pressure <55 mmHg or >90 mmHg.
• Presence of significant gastrointestinal abnormalities such as diarrhea or constipation;
• Safety laboratory abnormalities noted at screening which are clinically significant
• Current or defined history of abuse of alcohol or illicit drugs;
• A positive pregnancy test at screening;
• Poor vein access or fear of venipuncture or sight of blood; and
• Regular consumption of alcohol defined as either > 2 units (glass or shot) of alcoholic beverages per day or > 14 units per week.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biota Scientific Management Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Matson, MD

Role: PRINCIPAL_INVESTIGATOR

Prism Clinical Research

Locations

Prism Clinical Research

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

BTA798-102

Identifier Type: -

Identifier Source: org_study_id